The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Inclusion Criteria:

• Age ≥ 18 years at time of informed consent signature

• Informed Consent Form (ICF) is signed by the subject

• Subject can comply with protocol requirements, including follow-up

• Patient has symptomatic claudication, rest pain, or minor tissue loss (RutherfordCategory 2-5)

• Patient has de novo or restenotic lesion(s) found in the common and/or externaliliac artery(ies)

• Patient has: Unilateral or bilateral single or multiple lesions (>50% stenosis orchronic total occlusion) each between 4 and 11 cm in length

• Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm

• Patient has a sufficient (<50% stenotic) common femoral artery and at least onesufficient (<50% stenotic) femoral artery (deep or superficial).

• Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.

Exclusion Criteria:

• Life expectancy <1 year

• Patient is pregnant at time of informed consent.

• Patient has a known allergy to stent or stent graft components (including nitinol,stainless steel, or heparin).

• Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL)and not undergoing hemodialysis.

• Patient has evidence of a systemic infection.

• Patient has a known intolerance to antithrombotic medications that preventcompliance with study or control device Instructions for Use.

• Patient has had vascular catheterization of the lower extremities within 30 days ofrandomization (excluding diagnostic angiograms for the study procedure).

• Patient has previous stenting in the iliac arteries.

• Patient has previous surgical bypass in the target limb.

• Patient is currently participating in another investigative clinical study unlessreceived written approval by the sponsor.

• Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy,lithotripsy, or any ablative device to facilitate stent delivery.

• Patient has an abdominal aortic artery lesion or aneurysm.

• Patient has a lesion that requires stent placement within 2 cm of the inguinalligament.

• Patient has isolated common iliac artery stenosis that can be treated with a singledevice (i.e., common iliac artery stenosis that does not require kissing stents orextend into the external iliac artery).

• Patient has outflow disease that requires concomitant interventions (i.e. commonfemoral endarterectomy or femoral / tibial revascularization).